Hydrogen Peroxide Oral Rinse recalled over manufacturing violations

Recall date

January 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Den-Mat Holdings, LLC recalls Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bo…

Recall number

D-0287-2024

FDA classification

Class II

Brand / firm

Den-Mat Holdings, LLC

Sold / distributed

Nationwide in the US

Why it was recalled

CGMP Deviations: products may not conform to the labeled specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.